Neomend receives CE Mark for ProGEL PLATINUM Surgical Sealant

Jan 10 2011

Neomend, Inc., an innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company's ProGEL® PLATINUM Surgical Sealant.

“We will launch ProGEL PLATINUM, which is the recombinant or synthetic version of our sealant, in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology.”

"Receipt of the CE Mark positions Neomend to substantially grow its revenue on a worldwide basis," said David Renzi, the company's President and CEO. "This important milestone will enable us to help surgeons more effectively treat lung air leaks during lung resection surgery in countries outside the U.S., where there are many such procedures due to the prevalence of lung cancer."

The company estimates that approximately 150,000 lung resections are performed in the United States every year, with more than three times that number performed in other countries annually. Taken together, these procedures represent a worldwide market for lung surgery alone of more than $500 million. Future indications for ProGEL in other surgical sealing and anti-adhesion applications have market opportunities estimated to be well in excess of $1 billion.

"In the US we now have more than 500 hospitals routinely ordering ProGEL Pleural Air Leak Sealant, and it has already been used in more than 7,000 procedures since it became commercially available last April," Renzi said. "We will launch ProGEL PLATINUM, which is the recombinant or synthetic version of our sealant, in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology."

ProGEL PLATINUM Surgical Sealant is a hydrogel polymer consisting of two components: a biocompatible synthetic protein of recombinant albumin (Albucult®) and a cross-linking component of polyethylene glycol (PEG). When they are mixed together, a rapid crosslinking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal.

This technology addresses a surgical need to seal pleural air leaks incurred during lung surgery. Intraoperative air leaks are the most common complication of lung resection surgery and can lead to other complications such as infections, pneumonia and extended hospitalization.

ProGEL Pleural Air Leak Sealant received premarket approval from the U.S. Food & Drug Administration in January 2010 after a multi-center, prospective, randomized, controlled clinical study at five high-profile U.S. institutions demonstrated the sealant's clinical efficacy and also concluded that ProGEL led to a statistically significant reduction in intraoperative air leaks and hospital length of stay by nearly two days. It is the only sealant in the US approved for use on pleural air leaks following lung resection surgery.

Albucult® rAlbumin USP-NF is a product of Novozymes Biopharma UK Ltd. and Novozymes Biopharma DK A/S.